Panel Discussion – How Can These Experiences Inform Future Global Clinical and Regulatory Strategies?

Sunday, February 26, 2023

9:30 AM – 10:15 AM ET

Panel Moderator(s)

Aaron Lottes, PhD

Associate Professor of Engineering Practice
Purdue University
WEST LAFAYETTE, Indiana, United States

Disclosure(s): Merit Medical Systems Inc: Consultant (Ongoing)
Hiroyoshi Yokoi, MD

Director
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan

Disclosure information not submitted.

Panel Discussant(s)

Kenneth J. Cavanaugh, Jr., PhD

Deputy Director, Office of Cardiovascular Devices
U.S. Food and Drug Administration
Silver Spring, Maryland, United States

No relationships to disclose
Neal E. Fearnot, PhD

Vice President
Cook Group Incorporated
West Lafayette, Indiana, United States

Disclosure(s): Cook Medical: Employee (Ongoing)
Fumiaki Ikeno, MD

Researcher
Stanford University
Stanford, California, United States

No relationships to disclose
Mitchell Krucoff, MD, FACC (he/him/his)

Professor Medicine/Cardiology
Duke University Medical Center/Duke Clinical Research Institute
Durham, North Carolina, United States

Disclosure(s): Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)
Katherine Kumar, PhD, RAC

Sr. EVP
4C Medical Technologies, Inc.
Minnetonka, Minnesota, United States

Disclosure(s): 4C Medical Technologies, Inc.: Employee (Ongoing)
Stephen M. Rowland, PhD

Vice-President, Research and Development
OrbusNeich Medical Inc.
Fort Lauderdale, Florida, United States

Disclosure(s): OrbusNeich Medical Inc.: Employee (Ongoing)
Kate Stohlman, MBA, RAC (she/her/hers)

Vice President Quality Assurance & Regulatory Affairs
Corvia Medical, Inc.
Tewksbury, Massachusetts, United States

Disclosure(s): Corvia Medical, Inc.: Employee (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)
Zachary Woodson

Vice President of Regulatory Affairs & Quality
LimFlow Inc.

Disclosure(s): LimFlow: Employee (Ongoing)

Disclosure(s):

Aaron Lottes, PhD: Merit Medical Systems Inc: Consultant (Ongoing)

Neal E. Fearnot, PhD: Cook Medical: Employee (Ongoing)

Mitchell Krucoff, MD, FACC: Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)

Katherine Kumar, PhD, RAC: 4C Medical Technologies, Inc.: Employee (Ongoing)

Stephen M. Rowland, PhD: OrbusNeich Medical Inc.: Employee (Ongoing)

Kate Stohlman, MBA, RAC: Corvia Medical, Inc.: Employee (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Zachary Woodson: LimFlow: Employee (Ongoing)